Lacipil 2mg GSK tablets treat hypertension (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Lacidipine

Ingredient

Composition informationContent
Lacidipine2mg

Uses

indications

lacipil drugs are indicated in the following case:

Treatment Hypertension as a single treatment or combined with other hypertension medications such as beta blockers, diuretic and angiotensin (ACE).

.

Pharmacokinus

lacidipine is a strong and specific antagonistic antagonistic drug, which has a high selective effect for calcium channels on blood vessel muscles.

The main effect of the drug is peripheral artery, reducing peripheral vascular resistance and reducing blood pressure.

Observed that the phenomenon of about QTC is very small in volunteers after taking Lacipil 4 mg.

In a double blind study, randomly lasting 4 years Elsa (European Lacidipine Study on Atherosclerosis), the main criteria of effectiveness for atherosclerosis is the median of the pericid of the carotid artery (IMT) measured by ultrasound. The results in patients treated with lacipil show the effectiveness of significantly changing the endothelial thickness of the carotid artery, suitable for the anti -atherosclerotic effect of the drug.

pharmacokinetics

absorption:

After drinking, lacidipine is quickly absorbed but few gastrointestinal tract and parts are initially metabolized in the liver. Average average is about 10%. The peak concentration of plasma is reached from 30 to 150 minutes.

Metabolism:

There are 4 main metabolites with little pharmacological effects, if any. The drug is excreted mainly through the metabolism in the liver (related to P450 CYP 3A4). There is no evidence that lacidipine causes induction or inhibition of liver enzymes.

Era:

About 70% of the dose is eliminated in the form of metabolites through feces and the rest is excreted in the form of metabolites through urine.

Lacidipine average sale time is about 13 to 19 hours in a stable state.

Clinical safety data:

Lacidipine's only significant detections - reducing the ability to contract the heart muscle and gum hyperplasia in rats, dogs and constipation in mice can recover and suit the known pharmacological effects of calcium antagonists when using high doses.

There is no evidence of toxicity for the development after lacidipine pregnant rabbits or rats. In a study of fertility in the rat, it has found that the embryo is toxic to the mother and in accordance with the known pharmacological activity of the calcium antagonistic drugs on the uterus muscles, prolonging the pregnancy and difficulty in labor when taking high doses. Regarding pharmacological pharmacology, calcium antagonists are known to hinder the normal function of the uterus, leading to a decrease in the ability of uterine muscle contraction during labor.

lacidipine does not cause gene toxicity in a series of in vitro and in vivo tests. There is no evidence of the likelihood of cancer in mice. In a test of cancer birth in rats, as well as with other calcium antagonists, the drug causes increase in benign interstitial cell tumors in the testes. However, the hormonal mechanism is said to be related to the increase in interstitial cells and gland tumors in the rat, not related to humans.

Before taking Lacipil 2mg GSK tablets treat hypertension (4 blisters x 7 tablets)

How to use

Should take medicine at fixed hours every day, it is best to take the medicine in the morning, take the same or not with food.

Dosage

The starting dose is 2 mg x 1 time/ day.

Treatment of hypertension should be adjusted according to the severity of the disease and the response of each patient.

can increase the dose to 4 mg and if necessary to increase to 6 mg after a suitable time to achieve the sufficient pharmacological effects of the drug. In fact this time is not less than 3 to 4 weeks unless clinically requires faster dose increase.

can maintain treatment without time limit.

Hepatic failure:

No dose adjustments in patients with mild and medium liver failure. There is no enough data to recommend the use of drugs in patients with severe liver failure (see caution when used).

kidney failure:

No dose adjustments in patients with renal impairment due to lacidipine do not excreted through the kidneys.

Children:

There is no experience in lacidipine treatment for children.

Elderly:

No dose adjustment.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose?

Common perpetual peripheral vasodilation related to hypotension and tachycardia.

in theory can occur slowly heart rate or prolonging the atrial transmission.

There is no specific antidote. The standard treatment should be used to monitor the heart function and apply appropriate treatment and support methods.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using lacipil drugs, you may experience unwanted effects (ADR).

Data from clinical trials of large scale (internal and published) are used to determine the frequency of unwanted effects from very common to uncommon.

lacipil is usually well tolerated. Some individuals may experience unwanted effects related to the known pharmacological effect of the drug to cause peripheral vasodilation. These effects, marked by a promotion (#), often fleeting and disappears when continuing to use lacipil at the same dose.

Mental disorders:

Very rare ( depression .

Nervous system disorders:

  • Popular (≥ 1/100 and headache , # dizziness.

    • Very rare (

    Disorders on the heart:

  • Popular (≥ 1/100 and

    Not common (≥ 1/1000 and hypotension .

    • As well as other dihydropyridin, the drug worsens the hidden angina that has been reported in some individuals, especially when starting treatment. This phenomenon is more common in patients with symptomatic ischemia.

    circuit disorders:

    Popular (≥ 1/100 and

    Gastrointestinal disorders:

  • Popular (≥ 1/100 and

    Not common (≥ 1/1000 and

    Disorders on skin and subcutaneous tissues:

  • Popular (≥1/ 100 and

    Rare (≥ 1/10,000 and urticaria .

    • Kidney and urinary disorders:

    Popular (≥ 1/100 and

    Systemic disorders and at the place of use:

    Popular (≥ 1/100 and

    Unwanted effects are still in the process of researching and monitoring:

    Popular (≥ 1/100 and

    Notify the doctor with unwanted effects when taking the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated:

  • Too hypersensitivity to any ingredients of the drug (excipients: Lactose, Povidon K30, Magnesi Stearate, Opadry White YS-1-18043.).

    • Like other dihydropyridine, contraindicated use of lacipil for patients with severe aortic stenosis.

    Caution when using

    In specialized studies, lacidipine does not show that it has an impact on the spontaneous function of the atrial sinus button or causing prolonged transmission in the atrial node, but it should be noted that the theory of a calcium antagonistic drug has the ability to act on the operation of the sinus node and the atrial node, so it should be cautious when using the abnormalities and atrial button.

    As noted for other dihydropyridin -group calcium antagonists, should be cautious when taking lacipil in patients with congenital or congenital QT intervals. It is also advisable to be careful when taking Lacipil in patients treated simultaneously with known drugs that extend the QT interval such as anti -arrhythmia group I and III, 3 -round antidepressants, some anti -psychotic drugs, antibiotics (such as erythromycin) and some antihistamines (such as Terfenadine).

    Like other antagonists, should be cautious when taking lacipil in patients with poor heart reserves.

    As well as other dihydropyridin calcium antagonists, should be cautious when taking lacipil for patients with unstable angina.

    Should be cautious when taking lacipil in new patients with myocardial infarction.

    Should be cautious when taking lacipil in patients with liver failure because it can increase the effect of lowering blood pressure.

    There is no evidence that lacipil reduces glucose tolerance or changes in blood sugar control.

    The ability to drive and operate machinery

    lacidipine tablets can cause dizziness. Patients should be warned not to drive or operate machinery if they have dizziness or related symptoms.

    Pregnancy

    There is no data on lacipil's safety in pregnant women.

    Animal research does not show the effect of teratogenic or the development of the fetus (see the pharmacokinetic section of the property data section).

    Should only use lacipil for pregnant women when the benefit gives mothers outstanding unwanted effects that may occur for fetuses or babies.

    Consider the possibility of lacipil that can cause uterine muscle relaxation in women during pregnancy enough (see pharmacokinetic pharmacokinetic section of preclinical safety data).

    Lactation period

    Research on animals shows lacidipine (or its metabolic substances) can be excreted into breast milk.

    Should only use lacipil for breastfeeding mothers when the benefits bring mothers outstanding unwanted effects that can occur for the fetus or babies.

    Interactive drug

    Use lacipil in combination with other drugs that have other hypotension effects, including drugs that treat hypertension (such as diuretics, beta blockers or angiotensin transfer enzymes) can increase the effect of lowering blood pressure. However, specific interactive problems in studies with common hypertension medications (such as beta blockers and diuretic) or with digoxin, tolbutamid or warfarin.

    Lacipil levels in plasma may increase when used simultaneously with cimetidine.

    Lacipil is connected to protein (more than 95%), including albumin and alpha -1 -Glycoprotein.

    Like other dihydropyridine, lacipil should not be taken with grapefruit juice because it can be vanished.

    In clinical studies in kidney transplant patients with cyclosporin, lacipil reverses the reduction of plasma flow in the kidneys and the speed of glomerular filtration caused by cyclosporin.

    lacidipine is known to be metabolized by cytochrom CYP3A4. Therefore, strong touch and inhibitors CYP3A4 are used simultaneously can affect the metabolism and elimination of lacidipine.

    Storage

    Storage below 30 ° C.

    Store lacipil to avoid light, so do not remove the drug until removed to take out to take.

    If the dose is half of 4 mg, the remaining half of the pill should be held in the blister and used within 48 hours.

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